HIGH

Trifecta Pharmaceuticals Recalls Zinc Oxide Ointment Due to cGMP Deviations

Trifecta Pharmaceuticals recalled 33,000 containers of Globe Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. Consumers should stop using the product immediately to avoid potential risks. Healthcare providers are advised to contact the company for further guidance.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
ZINC OXIDE 20%, Trifecta Pharmaceuticals USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

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About This Product

Zinc oxide ointment is widely used for skin protection, particularly for treating diaper rash and minor skin irritations. Consumers purchase it for its soothing properties and effectiveness in creating a barrier on the skin.

Why This Is Dangerous

The recall is due to deviations in manufacturing practices that can lead to compromised product safety, such as contamination or incorrect potency levels.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face potential health risks by using the product, which may not be safe due to manufacturing deviations.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product packaging.
  2. Verify if your product has an expiration date of February 27 or 28, 2025.
  3. Look for the brand name 'Zinc Oxide 20%' or 'Trifecta Pharmaceuticals USA'.

Where to find product info

The lot number and expiration date can typically be found on the product label or bottom of the container.

What timeline to expect

Expect a refund processing timeline of approximately 4-6 weeks after submitting your request.

If the manufacturer is unresponsive

  • Follow up with the company via phone or email.
  • File a complaint with the FDA if you do not receive a response.

How to prevent similar issues

  • Always check for product recalls before purchasing over-the-counter medications.
  • Look for the FDA approval and cGMP compliance labels on health products.

Documentation advice

Keep records of your purchase, including receipts and any correspondence with the manufacturer.

Product Details

The recalled product is Globe Zinc Oxide Ointment USP, containing 20% zinc oxide, in 2 oz containers. Lot numbers include A502404 and A502405, with an expiration date of February 27, 2025, and AS02502, expiring February 28, 2025. The ointment was distributed nationwide in the USA.

Key Facts

  • 33,000 containers recalled
  • cGMP deviations identified
  • Stop using the product immediately
  • Contact healthcare provider for guidance

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #: A502404
Exp. Date 2/27
A502405
Exp. Date 2/27
AS02502
+1 more
UPC Codes
69396-086
69396-086-02
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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